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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019155

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NDA 019155 describes LAC-HYDRIN, which is a drug marketed by Ranbaxy and is included in two NDAs. It is available from one supplier. Additional details are available on the LAC-HYDRIN profile page.

The generic ingredient in LAC-HYDRIN is ammonium lactate. There are thirty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ammonium lactate profile page.
Summary for 019155
Ingredient:ammonium lactate
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019155
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAC-HYDRIN ammonium lactate LOTION;TOPICAL 019155 NDA Ranbaxy Laboratories Inc. 10631-098 N 10631-098-08
LAC-HYDRIN ammonium lactate LOTION;TOPICAL 019155 NDA Ranbaxy Laboratories Inc. 10631-098 N 10631-098-14

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:LOTION;TOPICALStrengthEQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 24, 1985TE:RLD:Yes

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